FOI release

Freedom of Information request (FOI 22/925)

Published 17 January 2024

FOI 22/925

1st September 2022

Dear

Thank you for your email, dated 23rd August 2022, in which you requested:

‘the Gilenya (fingolimod) targeted follow-up questionnaires and/or checklist for Progressive Multifocal Leukoencephalopathy (PML), Skin cancer, Seizures and Malignancy and Neoplasm/ Lymphoma, as required by the MHRA’

A copy of the information, which can be disclosed, is attached.

I hope the information provided is helpful; however, if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Please remember to quote the reference number above in any future communications.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division